Senior Production Quality Engineer – Medical Devices

Inbrain Neuroelectronics; Barcelona; Presencial; EUR 65.000 - 90.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Private Health Insurance

Training bonus

23 vacation days

Christmas week off

Bellaterra/Barcelona office

Descripción de la vacante

INBRAIN Neuroelectronics seeks a Senior Quality Engineer (Production) to lead production quality controls across manufacturing and microfabrication, ensuring documented readiness and robust processes. You will collaborate with internal teams and external partners to sustain safe, compliant medical devices.

The role emphasizes validation, equipment qualification, and QMS compliance, with a focus on risk-based improvements and data-driven decisions in a fast-moving environment.

Formación

• Bachelor’s degree in Biomedical Engineering, Industrial Engineering, Materials Science, Micro/Nanotechnology, LifeSciences or related technical field.
• 5+ years of experience in quality engineering within a regulated manufacturing environment, preferably medical devices, with demonstrated ownership of complex production quality activities.
• Strong experience with process validation, equipment qualification and manufacturing process controls.
• Working knowledge of ISO 13485 requirements for production, infrastructure, work environment, monitoring and measurement equipment, process validation, traceability, nonconforming product and CAPA.
• Demonstrated experience leading nonconformity investigations, root-cause analysis, CAPA and effectiveness verification.

Responsabilidades

• Own and continuously improve production quality controls across assigned manufacturing and microfabrication processes, ensuring alignment with approved SOPs, WINs, specifications, control plans, PFMEAs, inspection criteria and QMS requirements.
• Support implementation and maintenance of production controls, including line clearance, contamination control, environmental conditions, identification and traceability, prevention of product mix-up, in-process controls and final quality controls.
• Provide quality engineering oversight for assigned suppliers and CMOs, including review of quality performance, deviations, change notifications, calibration and maintenance evidence and manufacturing records.
• Lead complex nonconformity and quality investigations across production, facilities, equipment, cleanroom activities and suppliers.
• Own quality oversight for critical production and laboratory equipment, including qualification strategy, calibration and maintenance compliance, IQ/OQ/PQ review, requalification decisions and equipment-related deviations.

Conocimientos

Quality engineering

Regulated manufacturing

Root-cause analysis

CAPA

Technical coaching

Assertive communication

Fluent English

Educación

Bachelor’s degree in Biomedical Engineering, Industrial Engineering, Materials Science, Micro/Nanotechnology, LifeSciences or related technical field

Herramientas

Dot Compliance

MasterControl

Veeva Vault

MES/ERP/PLM environments

Descripción del empleo

INBRAIN Neuroelectronics seeks a Senior Quality Engineer (Production) to lead production quality controls across manufacturing and microfabrication, ensuring documented readiness and robust processes. You will collaborate with internal teams and external partners to sustain safe, compliant medical devices.

The role emphasizes validation, equipment qualification, and QMS compliance, with a focus on risk-based improvements and data-driven decisions in a fast-moving environment.